Three months ago at ASCO, Loxo Oncology wowed the crowd at the big cancer conference with some early-stage data for its second genetically targeted cancer drug candidate. Today, the biotech announced that the FDA seems similarly impressed, offering a breakthrough drug designation to shorten the regulatory timeline just as Loxo has hoped.
In the interim Phase I/II snapshot provided at ASCO, LOXO-292 spurred a 77% overall response rate for RET fusion-positive cases, the majority of which belonged to the non-small cell lung cancer. In RET-mutant medullary thyroid cancer the rate dropped to 45%.
Correspondingly, the BTD was granted for the treatment of two types of patients, both heavily pretreated: those with metastatic RET-fusion-positive non-small cell lung cancer who require systemic therapy and have progressed following chemo and checkpoint therapies; and those with RET-mutant medullary thyroid cancer needing systemic therapy who have progressed following prior treatment without any alternatives.
Stamford, CT-based Loxo $LOXO is one of the trailblazers in personalized cancer therapies, where patients are grouped no by the site of tumor development but by genetics — an approach that calls for broader sequencing to ID the genetic mutations underpinning each patients’ cancer.
Following a game plan that has catapulted larotrectinib to the final run-up of a widely expected approval in November, Loxo says it will design the next steps in clinical development based on feedback from regulators worldwide — with the final plan expected in 2019.
“We look forward to working with FDA to streamline the development of LOXO-292 in the two patient populations that have comprised the bulk of our initial clinical trial enrollment,” said Josh Bilenker. “Given the many available therapies for non-small cell lung cancer and medullary thyroid cancer, we are pleased that LOXO-292 has shown encouraging data in refractory patients, and hope to demonstrate the full potential of this treatment in additional populations over time.”
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 37,500+ biopharma pros who read Endpoints News by email every day.Free Subscription